SAXENDA comprises liraglutide, a GLP-1 receptor agonist that is an analogue of human GLP-1. Through swapping arginine for lysine at position 34, the peptide precursor of liraglutide, which is generated by the production of recombinant DNA in Saccharomyces cerevisiae, is 97% identical to native human GLP-1. Liraglutide is produced by joining a C-16 fatty acid (palmitic acid) and a glutamic acid spacer to the remaining lysine residue at position 26 of the peptide precursor.
Dosage Forms and Strengths:
SAXENDA is a colorless, transparent solution. SAXENDA solution includes 6 milligrams of liraglutide per 1 milliliter. Each prefilled pen contains a 3 mL solution of SAXENDA® containing 18 mg of liraglutide (free-base, anhydrous).
The recommended starting dose of SAXENDA is 0.6 mg once per day. After using SAXENDA® for one week, your dose should be raised until you reach the 3.0 mg level. After that, do not alter your dose unless instructed to do so by your healthcare provider. SAXENDA is administered once daily, at any time of day. SAXENDA can be taken with or without food. When you begin using SAXENDA, your physician should prescribe a diet and exercise program. Continue with this regimen while taking SAXENDA.
INDICATIONS AND CLINICAL USE:
SAXENDA (liraglutide) is suggested as an addition to a reduced-calorie diet and increased physical activity for the management of persistent weight gain in adult patients with an initial body mass index (BMI) of 27 kg/m2 or higher.
30 kg/m2 or greater (obese), or
27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity (e.g., hypertension, type 2 diabetes, or dyslipidemia) and who have failed a previous weight management intervention.eased further to 1.8mg daily.
DOSAGE FORMS, COMPOSITION AND PACKAGING:
SAXENDA is a prefilled, multidose pen for subcutaneous injection that gives dosages of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, and 3.0 mg (6 mg/mL, 3 mL).
POSSIBLE SIDE EFFECTS
- feeling sick (nausea), being sick (vomiting), diarrhea, constipation these usually go away after a few days or weeks
- lower appetite
- problems affecting the stomach and intestines such as: indigestion (dyspepsia), inflamed lining of the stomach (gastritis), stomach discomfort, upper stomach pain, heart burn, Feeling
- bloating, wind (flatulence), belching, dry mouth
- feeling weak or tired
- changed sense of taste
- injection site reactions (such as bruising, pain, irritation, itching and rash)
- low blood sugar (hypoglycemia) the warning signs of low blood sugar may come on suddenly.
- Do not use SAXENDA after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
- Before you start to use SAXENDA, store it in a refrigerator (2ºC to 8ºC) away from the freezer compartment. Do not freeze it.
- When SAXENDA is being used, you can keep it for 1 month either at room temperature (not above 30ºC) or in a refrigerator (2ºC to 8ºC).
- Do not use SAXENDA if it has been frozen.
- Always remove the injection needle after each injection and store your SAXENDA pen without an injection needle attached.
- This prevents contamination, infection, and leakage. It also ensures that the dosing is accurate.
- When you are not using the pen, keep the cap on. This will protect the medicine from light. Protect SAXENDA from high temperatures and sunlight.
- Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
- Keep out of reach and sight of children.
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